Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT00403169
Status:
COMPLETED
Last Update Posted:
2017-04-20
First Post:
2006-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer
Sponsor:
Organization:
Raw JSON
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Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.\n\nAfter completion of study treatment, patients are followed every 3 months.\n\nPROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed renal cell carcinoma (RCC)\n\n * Advanced or unresectable RCC\n* Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques OR ≥ 10 mm with spiral CT scan\n* No brain metastases\n\n * Brain metastases that have been treated with either radiotherapy or surgery and remain asymptomatic, with no active brain metastases, as shown by CT scan or MRI, for ≥ 6 months are allowed\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%\n* Absolute neutrophil count ≥ 1,500/mm³\n* Platelet count ≥ 100,000/mm³\n* Creatinine ≤ 2.0 mg/dL\n* Bilirubin ≤ 1.5 mg/dL\n* AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present)\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No other malignancies within the past 5 years, except for treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, localized prostate cancer, or superficial bladder cancer\n* No history of allergic reactions attributed to compounds of similar chemical or biological composition to lenalidomide or thalidomide\n* No uncontrolled intercurrent illness including, but not limited to, any of the following:\n\n * Ongoing or active infection\n * Symptomatic congestive heart failure\n * Unstable angina pectoris\n * Cardiac arrhythmia\n * Psychiatric illness or social situation that would limit study compliance\n* No hepatitis A, B, or C positivity\n* No HIV positivity\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No more than 1 prior systemic therapy for RCC (e.g., chemotherapy, hormonal therapy, immunotherapy)\n* At least 4 weeks since prior surgery, radiotherapy, hormonal therapy, chemotherapy, or immunotherapy and recovered\n* No prior lenalidomide\n* No other concurrent anticancer agents or treatments\n* No other concurrent investigational agents\n* No concurrent sargramostim (GM-CSF), radiotherapy, or thalidomide'}, 'identificationModule': {'nctId': 'NCT00403169', 'briefTitle': 'Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Phase II Study of CC-5013 in Patients With Advanced Renal Cell Carcinoma (RCC)', 'orgStudyIdInfo': {'id': 'CASE-CCF-7165'}, 'secondaryIdInfos': [{'id': 'P30CA043703', 'link': 'https://reporter.nih.gov/quickSearch/P30CA043703', 'type': 'NIH'}, {'id': 'CASE-CCF-7165'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lenalidomide for Advanced RCC', 'description': '25 mg/day Lenalidomide for 21 days per cycle.', 'interventionNames': ['Drug: lenalidomide']}], 'interventions': [{'name': 'lenalidomide', 'type': 'DRUG', 'otherNames': ['CC-5013'], 'description': 'drug', 'armGroupLabels': ['Lenalidomide for Advanced RCC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106-5065', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Robert Dreicer, MD, FACP', 'role': 'STUDY_CHAIR', 'affiliation': 'Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-05-24', 'type': 'RELEASE'}, {'date': '2017-06-19', 'type': 'RESET'}, {'date': '2018-01-26', 'type': 'RELEASE'}, {'date': '2018-02-22', 'type': 'RESET'}, {'date': '2018-07-26', 'type': 'RELEASE'}, {'date': '2018-07-27', 'type': 'RESET'}, {'date': '2023-10-10', 'type': 'RELEASE'}, {'date': '2023-10-10', 'type': 'RESET'}, {'date': '2025-07-15', 'type': 'RELEASE'}, {'date': '2025-08-01', 'type': 'RESET'}], 'unpostedResponsibleParty': 'The Cleveland Clinic'}}}}